Balloon sizing device with microelectromechanical sensors
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Solution Overview
Problem
Conventional methods for delivering and positioning collapsible prosthetic heart valves face challenges such as inaccurate sizing and positioning, leading to risks like valve migration, calcification issues, and complications due to anatomical variations, which can result in severe clinical outcomes.
Innovation Solution
A sizing device with a collapsible and expandable balloon equipped with microelectromechanical sensors that measure tissue properties, including annulus diameter and calcification levels, to ensure accurate fitment and reduce the risk of improper deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional imaging techniques are used to estimate valve annulus size, then the procedure is simple and quick, but the measurement precision is insufficient leading to inaccurate sizing
Solution Approach 1:
The patent replaces conventional imaging techniques (ultrasound, CT, MRI) with a direct mechanical measurement system. A catheter-based device with a balloon and force sensors is inserted into the heart, and the balloon is inflated to contact the native annulus tissue. The force sensors measure the contact force between the balloon and annulus, providing direct mechanical measurement of annulus size and properties, eliminating the need for complex imaging processing and interpretation.
Solution Approach 2:
The patent introduces a balloon as an intermediary element between the measurement system and the native annulus. The balloon is inflated to a controlled size and pressed against the annulus tissue, serving as a mediator that transfers force from the inflation system to the tissue. The force sensors attached to the balloon measure the interaction force, allowing indirect measurement of annulus properties through this intermediary contact mechanism.
2Reliability
If valve size is underestimated due to inaccurate measurement, then a smaller valve is implanted, but valve migration occurs leading to severe complications
Solution Approach 1:
The patent implements a feedback mechanism where force sensors on the balloon continuously measure the contact force between the balloon and native annulus during inflation. This force information is fed back to the operator in real-time, allowing adjustment of the balloon inflation pressure to achieve optimal contact force. The measured force serves as feedback to determine the correct valve size, ensuring the selected valve will properly anchor without migration.
Solution Approach 2:
The patent performs preliminary measurement of annulus size and tissue properties using the force-sensing balloon before the actual valve implantation. The balloon is inflated to contact the annulus, force measurements are taken, and based on these preliminary data, the appropriate valve size is selected. This preliminary assessment prevents improper valve sizing and subsequent migration during the actual implantation procedure.
3Object-affected harmful factors
If valve size is overestimated leading to oversized valve implantation, then local complications such as coronary orifice obstruction and aortic dissection occur
Solution Approach 1:
The patent measures multiple parameters beyond just annulus diameter, including contact force, tissue stiffness, and calcification presence. The force sensors detect not only the magnitude of contact force but also the mechanical properties of the tissue (compliance vs. calcification). These additional parameters provide comprehensive information about the implantation site, allowing selection of valve size that avoids overexpansion complications while accounting for tissue characteristics.
Solution Approach 2:
The patent performs preliminary assessment of tissue properties and annulus dimensions using the force-sensing balloon before valve selection. The balloon measures contact force and tissue compliance, identifying areas of calcification or abnormal tissue characteristics. This preliminary information guides the selection of appropriate valve size and type, preventing oversized valve implantation that could cause coronary obstruction or aortic dissection.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device enables precise measurement of native valve annulus dimensions and calcification, reducing the likelihood of valve migration and improper positioning, thereby enhancing the safety and effectiveness of prosthetic heart valve implantation.
Implementation Method 1
The at least one sensor may be capable of measuring data relating to native valve annulus diameter. The data relates to the extent of calcification of tissue and may utilize capacitance to measure the information.
Data Source
Figure 1
Figure 2A~2B
Figure 3A~3B
AI summary
A sizing device for a collapsible prosthetic heart valve, the sizing device includes a collapsible and expandable balloon having a proximal end, a distal end. At least one microelectromechanical sensor is coupled to the balloon, the at least one sensor being capable of measuring information related to size and stiffness of tissue.